Hypodermic needle assembly

ABSTRACT

A needle-syringe assembly comprises an elongated, generally cylindrical barrel which forms a hollow nozzle located at the distal end of the barrel and which opens into the interior of the barrel. A plunger is slidably mounted in the barrel and forms a longitudinal cavity. A needle holder carries a hollow needle on the distal end, and the needle holder is slidably mounted in the longitudinal cavity of the plunger. The needle holder includes a lateral arm which extends between the plunger cavity and the barrel. A spiral channel or slot forms a guide surface which extends along a proximal end portion of the barrel for engaging the lateral arm of the needle holder and retracting the needle holder within the barrel in response to relative rotational movement between the barrel and the needle holder.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 08/494,283 filed Jun. 23, 1995, now U.S. Pat. No. 5,643,222,which in turn is a continuation-in-part of U.S. patent application Ser.No. 08/229,811, filed Apr. 19, 1994, now U.S. Pat. No. 5,514,100, whichin turn is a division of application Ser. No. 08/111,372, filed Aug. 23,1993, now U.S. Pat. No. 5,338,311.

FIELD OF THE INVENTION

The present invention generally relates to hypodermic needles. Inparticular, the present invention relates to a needle-syringe assemblywhich conceals the sharp point of the hypodermic needle following use.

BACKGROUND OF THE INVENTION

A hypodermic needle has many applications in modern medicine. Oneapplication is to fit the hypodermic needle onto a syringe and to theninsert the needle into a person's body for intramuscular, subcutaneous,or intravenous injection of medications. A hypodermic needle enteringinto a patient's body is invariably contaminated by the patient's bloodand body fluids. Following use of the needle, the needle presents a riskto physicians, nurses, and other health care personnel because theneedle might transmit an infection or disease to such personnel if itwere to accidently puncture them. Thus, health care personnel are inconstant danger of contracting infections and diseases, some of whichmay be deadly. Other potential victims of accidental needle puncturesinclude sanitation workers which later dispose of garbage containing thehypodermic needle. The diseases which may be transmitted by acontaminated hypodermic needle include Immune Deficiency Virus,Hepatitis, Rabies, Kure, Encephalitis, and Arbor viruses. The outcome ofcontracting one of these diseases is often fatal because there are noknown cures for any of these diseases. Often a needle puncture in aperson's skin is so trivial that it remains unrecognized until theperson becomes seriously ill.

The problem of suffering accidental needle punctures is well recognized.As a result, enormous inventive effort has been devoted to concealingthe sharp needle point of hypodermic needles. One such effort isdescribed in the present applicant's U.S. Pat. No. 5,338,311, issuedAug. 16, 1994.

SUMMARY OF THE INVENTION

A primary object of the present invention is to improve theneedle-syringe assembly described in the aforementioned U.S. Pat. No.5,338,311.

One specific object of this invention is to provide an improvedneedle-syringe assembly which provides good structural stability for themechanism that is used to retract the needle after it has been used.

Yet another object of the present invention is to provide such animproved needle-syringe assembly which facilitates fabrication, andreduces the cost, of the assembly.

Still another object of the present invention is to provide such animproved needle-syringe assembly which facilitates the operation of theassembly, particularly when it is desired to retract the needle prior todisposing of the needle-syringe assembly.

Another object of the present invention is to provide such an improvedneedle-syringe assembly which improves the acceptability of the assemblyby providing an external appearance which is virtually the same as thatof conventional hypodermic needle assemblies which do not provide forneedle retraction.

A further object of the invention is to provide such an improvedneedle-syringe assembly that has the same length as conventionalhypodermic needle assemblies which do not provide for needle retraction.

Other objects and advantages of the invention will become apparent uponreading the following detailed description and upon reference to theaccompanying drawings.

In accordance with the present invention, the foregoing objectives arerealized by providing a needle-syringe assembly, operable in a normalmode and convertible to a retraction mode, comprising an elongated,generally cylindrical barrel forming a hollow nozzle located at thedistal end of the barrel and opening into the interior of the barrel; aplunger slidably mounted in the barrel and forming a longitudinal cavityextending between the distal end and the proximal end of the plunger; aneedle holder slidably mounted in the longitudinal cavity of theplunger; guide means forming a spiral channel extending along a proximalend portion of the barrel for retracting the needle holder within thebarrel in response to relative rotational movement between the barreland the plunger; and latching means on the barrel for latching andunlatching the needle holder at the distal end of the spiral channel.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation, partially in section, of a needle-syringeassembly embodying the present invention;

FIG. 2 is a section taken generally along line 2--2 of FIG. 1;

FIG. 2a is a section taken generally along line 2a--2a in FIG. 1, withthe plunger removed;

FIG. 3 is a plan view of the latching element included in theneedle-syringe assembly of FIG. 1;

FIG. 4 is the same view shown in FIG. 1, but with the plunger partiallyretracted;

FIG. 5 is the same view shown in FIG. 1 with the needle holder in theretracted position and the plunger in its fully advanced position;

FIG. 6 is a reduced longitudinal section of the barrel of theneedle-syringe assembly of FIG. 1;

FIG. 7 is an end elevation of the barrel of FIG. 6;

FIG. 8 is a reduced side elevation of the guide sleeve in theneedle-syringe assembly of FIG. 1;

FIG. 9 is an end elevation of the guide sleeve of FIG. 8;

FIG. 10 is an exploded view of the needle holder assembly in theneedle-syringe assembly of FIG. 1;

FIG. 11 is an enlarged section of the distal end portion of theleft-hand element of the needle holder assembly as shown in FIG. 10;

FIG. 12 is an enlarged section of the distal end portion of the barrelthat receives the needle holder assembly of FIGS. 10 and 11;

FIG. 13 is an enlarged section of the distal end portion of a modifiedbarrel for receiving a modified needle-holder assembly;

FIG. 14 is a fragmentary longitudinal section of the distal end portionof a modified needle holder assembly for use with the modified barrelshown in FIG. 13;

FIG. 15 is a side elevation of the plunger in the needle-syringeassembly of FIG. 1;

FIG. 16 is an end elevation of the distal end of the plunger of FIG. 15;

FIG. 17 is an end elevation of the proximal end of the plunger of FIG.15;

FIG. 18 is a side elevation of a modified plunger for use in theneedle-syringe assembly of FIG. 1;

FIG. 19 is an end elevation of the distal end of the plunger of FIG. 18;

FIG. 20 is an end elevation of the proximal end of the plunger of FIG.18;

FIG. 21 is a side elevation, partially in section, of a modifiedneedle-syringe assembly embodying the present invention;

FIG. 22 is the same view shown in FIG. 21 with the plunger partiallyretracted;

FIG. 23 is the same view shown in FIG. 21 with the needle and needleholder retracted and the plunger in its fully advanced position;

FIG. 24 is a side elevation, partially in section, of another modifiedneedle-syringe assembly embodying the present invention;

FIG. 25 is an end elevation of the proximal end of the assembly shown inFIG. 24;

FIG. 26 is a side elevation of the latch mechanism included in theassembly of FIGS. 24 and 25;

FIG. 27 is an end elevation of the proximal end of another modifiedneedle-syringe assembly embodying the invention;

FIG. 28 is a section taken generally along line 28--28 in FIG. 27;

FIG. 29 is a side elevation, partially in section, of a modified syringeembodying the invention;

FIG. 30 is an end elevation of the proximal end of the barrel in thesyringe of FIG. 29, with the latching element removed;

FIG. 31 is a partial side elevation of a modified barrel and latchdesign;

PIG. 32 is a section taken generally along line 32--32 in FIG. 31; and

FIG. 33 is a section taken generally along line 33--33 in FIG. 31.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

While the invention is susceptible to various modifications andalternative forms, specific embodiments thereof have been shown by wayof example in the drawings and will herein be described in detail. Itshould be understood, however, that it is not intended to limit theinvention to the particular forms disclosed, but on the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the invention as defined by theappended claims.

In order to satisfy the best mode requirement for this disclosure,several different modes of the invention, each with its own uniquefeatures and alternate embodiments, are described. Permutations andcombinations of these features will, however, lead to further modes.

Turning now to the drawings, FIGS. 1-12 and 15-17 illustrate aneedle-syringe assembly including a barrel 10, a plunger 11, a hollowplunger cap 12, a hypodermic needle 13, and a needle holder 14. Thebarrel 10 is a hollow cylinder which terminates in a hollow taperednozzle 15 at the distal end thereof, and has a slightly enlargeddiameter along a proximal end portion 16. The interior of the nozzle 15communicates with the hollow interior of the tubular body portion of thebarrel 10. An outwardly extending flange 17 near the proximal end of thebarrel 10 facilitates gripping of the barrel with the user's fingerswhen it is desired to move the plunger 11 relative to the barrel 10.

The purpose of the enlarged diameter of the proximal end portion 16 ofthe barrel 10 is to accommodate a sleeve 18 incorporating a spiral slot19 within its wall and without encroaching on the inner diameter of theentire syringe. As will be described below, this spiral slot 19 providesan internal retraction track for the needle holder 14 and the hypodermicneedle 13. The sleeve 18 and its spiral slot 19 extend along asufficient length to accommodate retraction of the needle holder 14through a distance that is sufficient to draw the entire length of theneedle 13 inside the barrel 10, as described in more detail below. Theouter surface of the barrel 10 preferably contains graduations (notshown) indicating the volume level of fluid in the barrel. Thesegraduations take into account the volume of the internal components suchas the needle holder 14.

The proximal end of the plunger 11 forms a knob 20 that can be graspedby a user to effect linear or rotary movement of the plunger 11 relativeto the barrel 10. The periphery of the knob 20 is serrated to facilitategripping of the knob for rotary movements of the plunger. The distal endof the plunger 11 forms a head 21 to accommodate the hollow rubberplunger cap 12. The outside diameter of the resilient cap 12 is reducedin the central portion so that the cap engages the inside wall of thebarrel 10 only at the pliable margins of the ends of the cap. Thediameter of the engaging end portions of the cap 12 is slightly largerthan the inside diameter of the barrel 10 so that the cap presses firmlyagainst the inside wall of the barrel to form an air-tight andliquid-tight seal at the cap/barrel interface. The inner margins of thecap 12 make a similar tight contact with the outer surface of the needleholder 14. The distal end 22 of the cap 12 is conical to conform to theconical distal end 23 of the inside surface of the barrel 10 when theplunger 11 is fully advanced within the barrel.

The head 21 of the plunger 11 is configured to fit tightly within thehollow plunger cap 12. With the cap 12 locked onto the head 21 of theplunger, the flat proximal end 24 of the cap abuts the flat surface of acircular disc 25 at the base of the plunger head 21. Due to theair-tight and liquid-tight seal between the plunger cap 12 and thebarrel 10, as well as the needle holder 14, advancing movement of theplunger 11 inside the barrel 10 creates pressure in the interior of thebarrel between the plunger cap and the distal end of the barrel.Similarly, retracting movement of the plunger 11 creates a vacuum inthat portion of the barrel interior.

The hypodermic needle 13 is mounted on the distal end of the elongatedneedle holder 14, which is detachably interlocked to the barrel 10.Prior to use of the needle-syringe assembly, the needle 13 is covered bya protective cap (not shown) which prevents needle pricks and preservessterility prior to use. Both the needle 13 and the distal portion of theneedle holder 14 are hollow, and the interior of the hollow needle 13communicates with the interior of the hollow distal portion of theneedle holder 14. The needle holder 14 further communicates with theinterior of the barrel 10 through an aperture 26 in the side wall of thehollow portion of the needle holder 14 (FIGS. 10 11 and 14). Prior toand during use of the needle-syringe assembly for injection of medicineor withdrawal of blood (hereafter referred to as "normal use"), theaperture 26 is positioned at the base of the barrel nozzle 15 FIG. 5),sometimes within a small cylindrical cavity 27. The aperture 26 permitsblood or medicine to enter or exit from the barrel 10 via the needleholder 14 and the needle 13.

During normal use of the needle-syringe assembly, the needle holder 14is locked to the barrel 10, and the plunger 11 and its cap 12 are freeto slide longitudinally back and forth along the needle holder. Theneedle holder 14 includes a metal tube 40 and an L-shaped metal rod 30having a longitudinal body portion 31 extending coaxially through thetube 40 to the aperture 26, and a lateral arm 32 extending radiallyacross the barrel 10 at the proximal end of the rod 30.

To permit relative sliding movement between the plunger 11 and theneedle holder 14 in the longitudinal direction, the needle holder ismounted in a longitudinal channel 33 formed as an integral part of theplunger 11. Multiple pairs of resilient retaining elements 34 (FIG. 15)project toward each other from the opposed walls of the channel 33 tohold the needle holder 14 within the channel. These retaining elements34 are deflected into adjacent recesses during insertion of the needleholder 14 into the channel 33, and then the elements 34 spring back totheir original positions after the needle holder is in place. It will benoted that the opposed walls of the channel 33 extend all the way to theinside wall of the barrel 10 (see FIG. 17), thereby constraining thelateral arm 32 of the needle holder against any angular or rotationaldisplacement relative to the plunger 11. That is, the plunger 11 and theneedle holder 14 can rotate only in unison with each other, althoughthey are free to move independently of each other in the longitudinaldirection. At the proximal end of the needle holder, a locking detent(described below) locks the arm and plunger together to prevent relativelongitudinal movement after retraction is complete.

A major portion of the stainless steel rod 30 is encased in a stainlesssteel hypodermic tube 40 which extends beyond the distal end of the rod30 and overlaps a portion of the needle 13. The opposed ends of theneedle 13 and the rod 30 are separated slightly from each other, and theintervening space is surrounded by the stainless steel tube 40 to form acavity 41 through which fluids pass between the hollow interiors of theneedle 13 and the barrel 10. The aperture 26 mentioned previously isformed in this portion of the tube 40.

To lock the needle holder 14 to the barrel 10, the outer surface of thedistal end portion of the metal cover tube 40 is ground (e.g., bycenterless grinding) to form a tapered surface 40a which mates with acomplementary tapered surface 15a on the inside wall of the barrelnozzle 15. These tapered surfaces 40a and 15a are conventionally knownas locking luer tapers, and the angle of the taper (typically 6% of thediameter) is conventionally known as a locking taper angle. In apreferred embodiment, the taper has a length between about 0.185 andabout 0.250 inch with a diameter of 0.094 inch at one end and a diameterof 0.082 inch at the other end.

The locking surfaces 15a and 40a are engaged during assembly of theneedle syringe, when the plunger 11 and needle holder 14 are insertedinto the barrel 10 through the open proximal end of the barrel. Theresultant locking luer taper can be released only by the application ofsimultaneous axial and rotational forces.

The proximal end of the needle holder 14 is also locked to the barrel10, via the lateral arm 32 of the metal rod 30. This arm 32 extendsradially beyond the plunger and fits into the spiral slot 19 in thesleeve 18. The arm 32 can be locked to the barrel 10 at either end ofthe spiral slot 19 and, when so locked, permits only reciprocal linearmovement of the plunger 11, to create vacuum to withdraw medication orblood and pressure to deliver medication to the patient via thehypodermic needle. When the arm 32 is locked at either end of the slot19, the plunger 11 cannot be rotated within the barrel 10.

When the user desires to retract the hypodermic needle 13 within thebarrel-plunger assembly, a mechanical latch 50 is manually actuated tounlock the arm 32 and thereby permit rotation of the plunger 11 relativeto the barrel 10. This relative rotation retracts and locks theneedle-needle holder assembly within the barrel-plunger assembly. Forthe needle and needle holder to be moved to the retracted position, theplunger 11 can be in any desired position, e.g., to permit blood ormedication to be retained in the syringe.

The preferred latch mechanism 50 of FIGS. 1-5 includes an arcuatelocking plate 51 and an integral handle 52 mounted for sliding movementwithin a short longitudinal slot 53 in the wall of the barrel 10. Thefree end of the plate 51 is angled to match the slope of the side wallsof the spiral slot 19, and the plate slides back and forth within a slot54 formed in the sleeve 18 and opening into the slot 19 adjacent thedistal end of the slot. The inner and outer radii of the plate 51 matchthose of the sleeve 18 (see FIG. 2) to ensure that the locking plate 51fits precisely into the slot 54 in the sleeve 18 and cannot fall insidethe barrel cavity to obstruct movement of the plunger 11, in either thelocked or unlocked position of the latch. As can be seen in FIG. 2, thelocking plate 51 and the handle 52 are offset from each other in theradial direction so that the handle rides on the outer surface of thebarrel 10. This outer handle surface is serrated to facilitate movementthereof with the user's finger or thumb.

The latch 50 can be opened or closed by linear movement of the lockingplate 51 via the handle 52. During normal use, the needle holder arm 32is positioned at the distal end of the spiral slot 19 and the lockingplate 51 is advanced into the spiral slot 19 to close the slot andretain the arm 32 at the distal end of the slot 19. This locks theneedle holder 14 in the normal operative mode in which only linearreciprocal movement of the plunger 11 is permitted. Because the lockingplate 51 blocks the spiral slot 19, the needle holder 14 cannot rotateand thus cannot travel along the spiral slot 19 for retraction of thehypodermic needle 13. When it is desired to retract the needle, thelatch handle 52 is retracted toward the distal end of the syringe,thereby opening the spiral slot 19 and permitting rotation of theplunger 11 and retraction of the needle holder 14 by movement of the arm32 along the spiral slot.

It will be appreciated that when the latch 50 is retracted to open thespiral slot 19 and thereby unlock the arm 32, the plunger can be in anydesired longitudinal position. That is, the plunger can be fullyadvanced, fully retracted, or at any intermediate position. This isadvantageous because it might be desired to retract the needle afteronly a portion of a dose of medication has been injected into thepatient, or it might be desired to retain a portion of a blood samplewithdrawn from a patient within the syringe. To prevent the leakage ofany fluid contained within the syringe at the time the needle isretracted, it is preferred to provide a latex seal (not shown) at theend of the nozzle 15.

To ensure retention of the end portion of the arm 32 within the spiralslot 19 during retracting movement of the needle holder 14, the plunger11 includes an integral circular retaining plate 55. The diameter ofthis plate 55 matches the inside diameter of the guide sleeve 18 so thatit tends to maintain the desired circular shape of the inside wall ofthe sleeve 18. Stresses exerted on the wall of the barrel during use cantend to distort the desired circular configuration of the sleeve 18, andif the distortion becomes large enough, the arm 32 can escape from thespiral slot 19. With the retainer plate 55 riding on the inside wall ofthe sleeve 18, however, such excessive distortion is prevented, and thusretention of the arm 32 within the spiral slot 19 is ensured. Of course,in addition to the retainer plate 55, the longitudinal ribs of theplunger also glide on the inside wall of the sleeve 18 at approximately90° intervals from each other, and thus further ensure that the sleeve18 retains its desired circular configuration.

During normal use of the needle-syringe assembly, the barrel 10 and theneedle holder 14 are held stationary, and the plunger 11 is free to moverelative to both the barrel 10 and the needle holder 14. Advancingmovement of the plunger 11 is limited by contact of the plunger cap 12with the end wall of the barrel 10, as shown in FIG. 1. Retractingmovement of the plunger 11 is limited by contact of the plunger disc 25with the arm 32. If desired, stop members may be provided on the insidesurface of the barrel to engage the disc 25 on the distal side of thelatch opening, to further protect against the leakage of fluids throughthe latch opening in the barrel wall. The needle holder 14 is locked tothe barrel 10 by virtue of the taper lock between the distal portion ofthe needle holder and the barrel nozzle 15, and the locking engagementof the lateral arm 32 in the wall of the barrel. Alternatively, theneedle holder can be locked to the nozzle by a threaded connection, asdescribed in more detail in U.S. Pat. No. 5,643,222. The plunger 11 isalso free to move longitudinally relative to the needle holder 14, asillustrated in FIG. 4, because the needle holder is not locked to theplunger in that direction. The locking of the lateral arm 32 to thebarrel wall prevents rotational movement of the plunger as well as theneedle holder, and also prevents the plunger from being accidentallypulled out. As long as the lateral arm 32 of the needle holder is lockedto the barrel wall, the needle-syringe assembly is in its normaloperating mode.

Following normal use of the needle-syringe assembly, the needle 13 canbe retracted into the plunger 11 and the barrel 10. This requires axialmovement of the needle holder 14 within the barrel 10 toward theproximal end thereof, which in turn requires that the needle holder 14be unlocked for movement along the spiral slot 19. Thus, to initiateretraction of the needle holder 14, the arm 32 is unlocked by retractingthe locking plate 51.

After the latching plate 51 has been retracted, the plunger knob 20 isturned to rotate the plunger 11 clockwise (as viewed from the proximalend) relative to the barrel. As the plunger is rotated, the needleholder 14 rotates in unison with the plunger because the arm 32 iscaptured between the opposed parallel walls of the channel 33 in whichthe needle holder is mounted in the plunger. Rotation of the needleholder 14 relative to the barrel (1) retracts the needle holder withinthe plunger by the camming action of the wall of the spiral slot 19acting on the arm 32, and (2) releases the locking luer taper at thedistal end of the barrel nozzle 15 due to the resulting compoundrotational and longitudinal forces applied to the tapered surfaces 15aand 40a. As rotation continues, the arm 32 traverses the entire lengthof the spiral slot 19, thereby retracting the entire needle holder 14through a corresponding axial distance within the plunger 11 (see FIG.5). Of course, the needle 13 is retracted along with the needle holder14, and thus the needle is retracted completely within the barrel nozzle15 and the plunger 11, as illustrated in FIG. 5.

In the illustrative embodiment, the spiral slot 19 is formed in a sleeve18 fitted inside a distal end portion of the barrel 10, and attached tothe barrel. The spiral slot preferably has a constant rate of curvaturealong its length. The portion of the barrel 10 that receives the sleeve18 has a slightly larger diameter than the central portion of thebarrel, and the sleeve 18 has the same inside diameter as the centralportion of the barrel. Alternatively, a spiral channel can be molded asa part of the inside wall of the end portion of the barrel that has theslightly larger diameter. The illustrative syringe need not be anylonger than a conventional syringe because conventional syringes aremade longer than required to provide more than the desired fluid volume,so as to avoid inadvertent withdrawal of the plunger and the resultantspillage of the syringe contents. The extra barrel length alsoaccommodates the user's fingers in the space between the plunger knoband the finger flanges. The present invention permits the extension ofthe barrel length in this area to be used for the needle-retractingmechanism.

To attach the sleeve 18 to the barrel 10, three tabs 18a, 18b, 18cextend radially outwardly from the sleeve 18 into complementary notches10a, 10b, 10c in the distal end of the barrel. To lock the sleeve to thebarrel longitudinally as well as rotationally, four fingers 18d-18g onopposite sides of the sleeve 18 snap into complementary recesses 10d-10gon the inside wall of the barrel.

At the distal end of the spiral slot 19, the end of the arm 32 snapsinto a detent notch 19a (FIGS. 1, 4 and 5) formed by the walls of theslot so that the user feels the end of the needle retraction, as aclick. Then if the user attempts to turn the plunger knob 20 in theopposite direction, such attempt is met with firm resistance. This is asafety feature to prevent the needle from being returned beyond the endof the barrel nozzle, and to discourage re-use of the needle.

A pair of resilient locking fingers 56 (FIG. 15) are formed in theopposed walls of the channel 33 near the proximal end thereof to preventthe plunger 11 from being withdrawn from the barrel 10 after the needleholder 14 has been retracted. The arm 32 deflects the fingers 56 intoadjacent recesses as the arm is retracted past the fingers, but the arm32 then blocks any effort to retract the plunger 11 over the 20 needleholder 14.

FIGS. 18-20 illustrate a modified plunger for use with a needle holderhaving a larger diameter than the needle holder used with the plunger ofFIGS. 15-17. For example, the relatively thin needle holder of FIG. 11can be used in the plunger of FIGS. 15-17, and the larger-diameterneedle holder of FIG. 14 can be used in the plunger of FIGS. 18-20. Itwill be noted that the passageway 33 is wider in the plunger of FIGS.18-20 than in the plunger of FIGS. 15-17. Similarly, the hole thatextends through the distal end of the plunger is also larger in FIG. 19than it is in FIG. 16. Certain of the details of the plunger of FIGS.15-17, such as the retaining elements 34 and the fingers 56, have notbeen included in the illustration of the plunger in FIGS. 18-20, but itwill be understood that similar features may be included in bothplungers.

To operate the needle-syringe assembly, the protective cap (not shown)is removed from the needle 13, and the required amount of medication isaspirated into the barrel 10. Next, the injection site on the body of apatient is determined and the skin is cleaned with an antisepticsolution. Following percutaneous entry of the needle into the patient,location of the needle tip in the vein is confirmed by aspirating asmall amount of blood into the transparent barrel 10. The plunger 11 isthen advanced to force the medication from the barrel 10 into the vein.After the medication is administered, the needle 13 is withdrawn fromthe patient, the latch handle 52 is retracted to open the spiral channel19, and the plunger knob 20 is rotated clockwise until the user feelsthe arm 32 snap into the detent notch 19a at the proximal end of thespiral slot 19. The spiral slot 19 may alternatively be configured torequire counterclockwise, instead of clockwise, rotation of the plungerknob 20. With the needle 13 completely retracted inside the barrel 10,the needle-syringe assembly can be safely discarded in its entirety.

It can be seen from the foregoing description that the needle-syringeassembly performs all the conventional functions of injection syringesand yet, upon completion of injection, the hypodermic needle 13 isconcealed within the barrel 10. The needle-syringe assembly can receiveand disperse medications any number of times for a given patient byreciprocal longitudinal movement of the plunger 11 within the barrel 10.Another advantage of the needle-syringe assembly is that its designprevents the plunger 11 from slipping out of the barrel 10 during normaluse of the assembly.

The needle-syringe assembly of this invention is easy to manufacture,cost-effective, and easy to use in the field. The parts can all be madeby conventional plastic molding and using readily available metal needlestock. The plastic parts can be made by injection molding medical gradepolymers such as polypropylene. The; plunger seal or cap can be moldedfrom natural or synthetic elastomeric polymers. The guide sleeve withthe spiral slot can be molded and press fit into the wide end of thebarrel. The spiral channel on the inside wall of the barrel can bemolded with rotating cores which are removed by rotating them whilewithdrawing them from the 30 molded part.

The final assembly is compact because the needle holder 14 is retracteddirectly into the plunger 11 itself, and thus the plunger 11 need not befully extended for needle retraction to occur. When discarded followinguse, the needle-syringe assembly contributes minimally to the bulk ofrefuse. Since retraction of the needle 13 is effected by turning theplunger knob 20 at the proximal end of the assembly, the hand of a userdoes not come into the vicinity of the needle point, thereby minimizingthe possibility of a needle prick during retraction. Moreover, theassembly employs substantially the same number of components asconventional syringes, and does not require additional guards, sheaths,sleeves, springs, etc. to conceal the needle following use.

FIGS. 13 and 14 illustrate a modified construction for locking thedistal end of the needle holder 14 to the barrel nozzle 15. In thisdesign the distal end of the tube 40 abuts a shoulder on a plasticinsert 42 bonded to that portion of the needle that is within the barrelnozzle 15. This insert 42 fits tightly against the inside surface of thenozzle 15, and these mating surfaces of the insert 42 and the nozzle 15are tapered to form a conventional locking luer taper (typically 6% ofthe diameter). Specifically, the inside surface of the nozzle 15 forms alocking female luer taper 43, and the outside surface of the insert 42forms a locking male luer taper 44. In the preferred embodiment, theinside diameter of the nozzle 15 varies from 0.0737 inch at the proximalend of the taper to 0.0625 inch at the distal end of the taper. Thelongitudinal distance between these two inside diameters is 0.1875 inch.The diametric difference between the two diameters forms a locking luertaper in the nozzle 15.

A modified embodiment and latch mechanism is shown in FIGS. 21-23. Inthis embodiment, a spiral channel 60 is integrally molded on the innersurface of a proximal end portion 61 of a barrel 62. To accommodate thespiral channel 60, the wall thickness of the barrel 62 is increased inthe end portion 61. Internal molding of the spiral channel 60 ispossible when mold cores are rotated while they are pulled from the moldcavity used to form the barrel 62. A latch mechanism 63 is mounted in astraight longitudinal slot 64 that opens through the proximal end of thebarrel 62 and continues as a straight longitudinal channel 65 on theinside wall of the barrel 62. The spiral channel 60 preferably extendsless than 360 degrees around the circumference of the barrel 62, andopens through the proximal end of the barrel. This avoids interferencebetween the spiral slot 60 and the channel 65. The slot 64 receives aserrated latch handle 66 that fits precisely into the slot 64 but isshorter than the slot in the axial direction and mates with recesses inthe side walls of the slot 64. The handle 66 is molded on a metal pin 67that extends distally beyond the slot 64 and along the entire length ofthe channel 65 which opens into the end portion of the spiral channel 60adjacent the distal end thereof. The external surface of the handle 66is serrated to facilitate frictional gripping for capture and release ofthe needle holder arm by the latching pin 67.

During assembly, the right-angle needle holder arm 32 is engaged in thespiral channel 60 through its open end, and then the end of the spiralchannel is closed by heat crimping. The needle holder 14 is advanceduntil the arm 32 reaches the distal end of the spiral channel 60. Atthis location the needle holder arm 32 is locked in its advancedposition in the spiral channel 60 by advancing the handle 66 so that thepin 67 enters and blocks the spiral channel 60. This prevents rotationof the needle holder 14 so that it cannot be moved along the spiralchannel 60. Linear movements of the plunger 11 do not affect the pinengagement that is perpendicular to the spiral. When it is desired toretract the needle 13, the handle 66 is retracted to the proximal end ofthe barrel 62 to retract the pin 67 and open the spiral channel 60,thereby permitting rotation of the plunger 11 and resultant retractionof the needle holder 14 via the spiral channel.

Yet another modified embodiment and latch mechanism is shown in FIGS.24-26. In this embodiment, the needle holder 14 with a relatively shorthypodermic needle 13 is engaged in a barrel 70 having the normal fingerflange 17 and extended barrel length to reach the plunger knob 20. Inthis embodiment, the spiral track for retracting movement of the arm 32is formed by a spiral slot 71 which extends through the entire thicknessof the barrel wall. It will also be noted that the barrel 70 has auniform wall thickness, and a uniform outside diameter, along its entirelength, including that portion of the barrel in which the spiral slot 71is formed and extends well beyond the finger flange to the plunger knob.This greatly facilitates molding of the barrel, including the spiralslot 71, without the use of any special technique. It will beappreciated that the position of the finger flange and the length of thebarrel extension on the proximal side of the flange can be varied asrequired to retract needles of different lengths.

The distal end of the spiral slot 71 terminates within the thickness ofthe finger flange 17. Moreover, the radial length of the needle holderarm 32 is extended so that the end of the arm 32 projects beyond theouter surface of the barrel 70 and into a groove 72 formed in the flange17, as a continuation of the distal end portion of the spiral channel 71formed in the wall of the barrel. Consequently, when the arm 32 ispositioned at the distal end of the spiral slot 71, the radially outerend portion of the arm 32 is positioned in the groove 72 formed in theflange 17.

This permits the use of a latch mechanism mounted on, or formed as apart of, the finger flange 17. A bead of resin may be glued to the endof the needle holder arm 32 projecting beyond the barrel wall to ensurethat the arm remains engaged in the spiral slot 71.

In the particular embodiment illustrated in FIGS. 25 and 26, a latch 74is molded as an integral part of the finger flange 17. The latch 74includes an arm 75 connected to the flange 17 by a thin hinge 76 so thatthe arm 75 can be pivoted over the flange 17 to clamp the needle holderarm 32 against the flange 17. An L-shaped extension 77 on the free endof the arm 75 snaps over the flange 17 (see FIG. 26) to hold the arm 75in its closed position until it is released by pressing on a rib 78projecting from the opposite side of the arm 75. This is an advantageousconstruction in that it permits the latch to be molded as an integralpart of the barrel 70.

An alternative latch construction for use with a circular finger flangeis shown in FIGS. 27 and 28. In this embodiment, a separately molded,U-shaped latch element 80 fits over the portion of the flange 17 thatcontains the end portion of the needle holder arm 32. A series ofdetents 81 formed in the mating surfaces of the circular flange 17, asecond flange 82 formed as an integral part of the barrel surface andthe latch element 80 serve to hold the latch in position on the flange.

FIG. 29 illustrates a syringe similar to the syringe of FIG. 24 in thatthe spiral channel 60 extends through the wall of the barrel. In thedesign of FIG. 29, however, the spiral channel 60 is covered by separatesleeve 90 which is telescoped over, and attached to, the barrel 62. Thissleeve 90 also forms the finger flange 17. This construction isparticularly desirable when a portion of the spiral channel is locatedon the distal side of the finger flange 17, because that portion of thebarrel is often gripped by the person using the syringe, and the smoothsleeve 90 has a better feel than a barrel surface having a spiralchannel extending through the wall.

FIG. 30 is an end view of the proximal end of the barrel 62 and thesleeve 90 with the latch 63 removed. It can be seen that the slot 64 forthe latch is formed in both the barrel 62 and the surrounding sleeve 90,and a hole 92 for the latching pin 67 is formed by the mating surfacesof the barrel 60 and the sleeve 90. Half of the hole 92 is formed in theinner surface of the sleeve 90, while the other half of the hole isformed in the outer surface of the barrel 62. When these two members areassembled, the mating surfaces form a circular hole 92 for receiving thelatching pin 67.

FIGS. 31-33 illustrate another modified barrel and latch. The barrel 100in this embodiment is stepped at 101 so that both the inside diameterand the outside diameter of the barrel increase in the region containingthe spiral channel, which is not shown in FIGS. 30-31. Because of theincrease in the inside diameter of the barrel, the plunger will besupported only in the distal portion 102 of the barrel, while in theproximal portion 103 of the barrel a small gap will exist between theouter periphery of the plunger and the inner periphery of the barrel.The plunger will still be coaxially supported within the barrel becausea substantial length of the plunger is always engaged within the distalportion 102 of the barrel. A channel 104 is formed in the inside surfaceof the proximal barrel portion 103 for receiving a latch 105. Thesidewalls of the channel 104 guide and stabalize the latch 105 as it ismoved back and forth between its advanced (closed) position within thespiral channel and its retracted (open) position outside the spiralchannel.

I claim:
 1. A needle-syringe assembly, comprising:an elongated,generally cylindrical barrel forming a hollow nozzle located at thedistal end of said barrel and opening into the interior of said barrel;a plunger slidably mounted in said barrel and forming a longitudinalcavity; a needle holder slidably mounted in said longitudinal cavity ofsaid plunger; guide means forming a spiral channel extending along aproximal end portion of said barrel for engaging a lateral extension ofsaid needle holder and retracting said needle holder within the barrelin response to relative rotational movement between the barrel and theplunger, and latching means on said barrel for latching and unlatchingsaid lateral extension of said needle holder at the distal end of saidspiral channel.
 2. The needle-syringe assembly of claim 1 wherein saidlatching means comprises a needle holder locking element slidablymounted on said barrel for reciprocating movement between a lockingposition within said spiral channel and a non-locking position outsidesaid spiral channel.
 3. The needle-syringe assembly of claim 2 whereinsaid latching means includes a manually actuatable handle attached tosaid needle holder locking element and exposed on the outer surface ofsaid barrel for effecting sliding movement of said needle holder lockingelement.
 4. The needle-syringe assembly of claim 2 wherein said latchingmeans is slidably mounted in a channel formed in said barrel and openinginto said spiral channel at one end of the channel, and opening throughthe end of said barrel at the other end of the channel.
 5. Theneedle-syringe assembly of claim 1 wherein said plunger includescontacting means extending transversely across the interior of saidbarrel and sliding along the interior surface of said barrel that formssaid spiral channel so as to maintain the desired configuration of thatsurface and thereby ensure engagement of said needle holder within saidspiral channel.
 6. The needle-syringe assembly of claim 5 wherein saidcontacting means includes a circular plate formed as an integral part ofsaid plunger.
 7. The needle-syringe assembly of claim 5 wherein saidcontacting means also includes a plurality of longitudinal elementsformed as integral parts of said plunger and sliding along the interiorsurface of said barrel to maintain the desired configuration of thatsurface.
 8. The needle-syringe assembly of claim 1 wherein said barrelincludes an outwardly extending finger flange to facilitate gripping ofthe barrel, the distal end of said spiral channel terminates with saidflange, and said needle holder extends radially through the barrel wallto said flange.
 9. The needle-syringe assembly of claim 8 wherein saidlatching means is moveable over said flange to capture the portion ofsaid needle holder that extends onto said flange.
 10. The needle-syringeassembly of claim 1 wherein said spiral channel is formed in the wall ofsaid barrel and extends radially through the wall of said barrel. 11.The needle-syringe assembly of claim 10 which includes an outer sleevetelescoped over said barrel and covering at least a distal end portionof said spiral channel.
 12. The needle-syringe assembly of claim 1wherein said latching means includes a longitudinal latching pinslidably mounted in the wall of said barrel for movement between aretracted (open) position outside said spiral channel and an advanced(closed) position in which the pin extends across said spiral channel toblock the channel and capture said needle holder at the distal end ofthe channel.
 13. The needle-syringe assembly of claim 12 wherein saidspiral channel extends radially through the wall of said barrel andwhich includes a sleeve telescoped over said barrel and covering saidspiral channel, the mating surfaces of said barrel and said sleeveforming a longitudinal passageway for receiving said latching pin. 14.The needle-syringe assembly of claim 1 wherein the portion of saidbarrel containing said spiral channel has a larger inside diameter thanthe distal portion of said barrel, and said latching means slides on theouter surface of said proximal portion of the barrel and on the innersurface of the barrel portion containing the spiral channel.
 15. Theneedle-syringe assembly of claim 14 wherein the inner surface of thebarrel portion containing the spiral channel forms a longitudinalchannel for receiving and guiding said latching means.
 16. Theneedle-syringe assembly of claim 1 wherein said lateral extensioncomprises a lateral arm extending laterally through said plunger cavityto said barrel, and said latching means is mounted for movement out ofsaid spiral channel for capturing and releasing said needle holder armat the distal end of said spiral channel.
 17. The needle-syringeassembly of claim 1 which includes a hollow needle attached to thedistal end of said needle holder.
 18. The needle-syringe assembly ofclaim 1 wherein said spiral channel includes means at the proximal endthereof for resisting advancing movement of said needle holder after ithas been fully retracted.
 19. The needle-syringe assembly of claim 1which includes a detent at the distal end of said spiral channel. 20.The needle-syringe assembly of claim 1 wherein said latching meansincludes a slidable plate which forms a distal end portion of a sidewall of said spiral, channel when said plate is in a retracted (open)position, and which blocks said channel and captures said needle holderat the distal end of said channel when said plate is in an advanced(closed) position.
 21. The needle syringe assembly of claim 1 whereinsaid cavity of said plunger forms locking fingers, said locking fingerssecuring said arm of said needle holder in place.